# EUR-Lex - 52013PC0168 - EN

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# 52013PC0168

**Amended proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems /* COM/2013/0168 final - 2012/0035 (COD) */**

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EXPLANATORY MEMORANDUM*

1.           CONTEXT OF THE PROPOSAL

·
General context

The legislation of the Union requires a
marketing authorisation to be granted by the competent EU or national
authorities before any medicinal product can be placed on the market.[1] The rules in force aim to
safeguard public health by ensuring that the quality, safety and efficacy of
medicines are properly evaluated before these can be made available to patients
in the European Union. This legislative framework also intends to facilitate trade
in medicines between Member States in accordance with the principle of free
movement of goods.

Meanwhile, pursuant to Article 168(7) of
the Treaty on the Functioning of the European Union, Member States are
responsible for the organisation of their healthcare system and for the
delivery of health services and medical care, including the allocation of
resources assigned to them. In this framework, each Member State can take measures to manage the consumption of medicines, regulate their prices or establish
the conditions of their public funding. A medicinal product authorised in
accordance with EU legislation on the basis of its quality, safety and efficacy
profile may therefore be subject to additional regulatory requirements at Member State level before it can be placed on the market or dispensed to patients under the
public health insurance scheme. For instance, Member States usually evaluate
the cost-effectiveness of authorised medicines, or their relative efficacy as
well as the short- and long-term effectiveness compared to other products in
the same therapeutic class, in order to determine their price, funding and
utilisation in the framework of their health insurance system.

National measures to control the funding of
medicines and manage their consumption in the framework of healthcare systems
are susceptible to create barriers to trade as they affect the capacity of
pharmaceutical companies to sell their products in domestic markets. The
settled case-law of the Court of Justice of the European Union recognises the
right of Member States to adopt such measures in view of promoting the
financial stability of their health insurance system.[2] However, basic conditions of
procedural transparency must be met to ensure their

- N.B. Provisions which have been introduced in the proposal
compared to the initial proposal are indicated in bold, italic and underlined.
Deleted provisions of the initial proposal are indicated in strikethrough.

compatibility with the rules of the Treaty
relating to the Single Market. In particular, pricing and reimbursement
measures must be free of discrimination against imported medicinal products and
based on objective and verifiable criteria which are independent from the
origin of the products.

Directive 89/105/EEC[3] codifies the minimum
requirements set forth by the Court of Justice. It was adopted to enable market
operators to verify that national measures regulating the pricing and
reimbursement of medicines do not contravene the principle of free movement of
goods. To this end, the Directive lays down a series of procedural requirements
to ensure the transparency of pricing and reimbursement measures adopted by the
Member States. These obligations include specific time limits for pricing and
reimbursement decisions (90 days for pricing, 90 days for reimbursement or 180
days for combined pricing and reimbursement decisions). The Directive also
requires the competent national authorities to provide a statement of reasons
based on objective and verifiable criteria for each of their decisions and to
provide appropriate legal remedies to the applicant companies.

·
Grounds for and objectives of the proposal

Directive 89/105/EEC has never been amended
since its adoption. Its provisions reflect the pharmaceutical market conditions
which prevailed more than twenty years ago. However, these conditions have
fundamentally changed, for instance with the emergence of generic medicines
providing cheaper versions of existing products or the development of
increasingly innovative (yet often expensive) research-based medicinal
products. In parallel, the constant rise in public expenditure on
pharmaceuticals in the last decades has encouraged Member States to devise more
complex and innovative pricing and reimbursement systems over time.

Despite the historically positive impact of
Directive 89/105/EEC on the internal market for medicines, there is evidence
that it does not fully achieve its objectives in the present context:

–
Firstly, a gap has emerged between the
provisions of the Directive, which describe the main types of pricing and
reimbursement procedures established in the 1980s, and the much wider range of
cost-containment measures adopted nowadays by Member States. Despite the
extensive interpretation of the Directive by the Court of Justice[4], the implementation of its
provisions in national law and the effective enforcement of its principles, in
particular by the Commission, have become particularly challenging. This
situation not only results in legal uncertainties but also in a reduced transparency
of national pricing and reimbursement measures, which negatively affects the
smooth functioning of the internal market to the detriment of European patients
and pharmaceutical companies.

–
Secondly, the time limits for pricing and
reimbursement decisions established by Directive 89/105/EEC are regularly
exceeded by Member States. This leads to delays in the marketing of medicinal
products, which in turn slows down the availability of valuable treatments for
patients. In 2009, the Commission’s Competition Inquiry into the Pharmaceutical
Sector[5]
recalled that Member States should comply with these time limits. The inquiry
also demonstrated that unnecessary delays in the pricing and reimbursement of
generic medicines delay patients’ access to cheaper medicines and increase the
financial burden on Member States. The Commission therefore considered that
pricing and reimbursement procedures should be shortened with respect to
generic medicinal products. In addition, the sector inquiry showed that the
interference of patent or safety related issues with pricing and reimbursement
processes can significantly delay access to cheaper generic medicinal products.

The fundamental objectives and principles
of Directive 89/105/EEC remain fully valid in the present context. Accordingly,
this initiative aims at adapting the Directive to the current pharmaceutical
environment while preserving its core foundations. The overall objective of the
proposal is to clarify the procedural obligations incumbent upon Member State and to ensure the effectiveness of the Directive, both in avoiding delays in
pricing and reimbursement decisions and in preventing barriers to
pharmaceutical trade. This shall be done without affecting national social
security policies, except as far as it is necessary to achieve the transparency
of national procedures and the effectiveness of the internal market
legislation.

2.           RESULTS OF CONSULTATIONS WITH THE
INTERESTED PARTIES AND IMPACT ASSESSMENTS

·
Consultation of interested parties

A public consultation on a possible
revision of Directive 89/105/EEC was held from 28 March to 30 May 2011. In
response to this consultation, the Commission received 102 contributions from a
broad range of stakeholders including national authorities, public health
insurers, individual companies and organisations representing the
research-based pharmaceutical industry, the generic industry, the medical
devices industry and other interested parties such as representatives of the
distribution chain, health professional organisations, patients and citizens.
Small and medium sized enterprises were also consulted through the Enterprise
Europe Network.

A large majority of respondents recognised
the positive impact of the Directive on the transparency of national procedures
and the functioning of the internal market. However, many of them also pointed
to its weak implementation by Member States and highlighted its shortcomings in
terms of legal clarity and enforcement. Opinions differed as to the relevant
actions which should be proposed by the Commission. For instance, the generic
industry unanimously advocated a revision of the Directive, while
research-based companies and their representative organisations favoured a soft
law approach based on an interpretative Communication by the Commission.

The results of the public consultation are
available at: http://ec.europa.eu/enterprise/sectors/healthcare/public-consultation/index_en.htm.
Impact assessment

Responses to the public consultation were
carefully considered during the impact assessment carried out by the Commission
services. The impact assessment report identifies and assesses regulatory and
non-regulatory options to achieve the overall objective of ensuring that
adequate and effective transparency rules apply to the pricing and
reimbursement measures adopted by Member States. The proposal to revise the
Directive is based on the combination of options recommended in the framework
of the impact assessment, namely:

–
To ensure timely pricing and reimbursement
decisions: options A.3/c (regular reports on
pricing and reimbursement approval times), A.4/a (shorter time-limits for
pricing and reimbursement decisions concerning generic medicinal products) and
A.4/b (prohibition of patent linkage and re-assessment of safety features).

–
To ensure the adequacy and effectiveness of
the Directive in the current context: options B.3/b
(extensive revision of the Directive to clarify its scope and wording) and B.4
(notification of draft national measures to facilitate enforcement).

The possible extension of the Directive to
include medical devices was examined in the impact assessment but discarded due
to the specificities of this market.

Furthermore, in spite of the difficulty
to conclude on the overall cost-benefit balance of reducing the time limits
with respect to originator medicines, a reduction from the current 90/180 days
to 60/120 days is proposed in light of the positive impact it would have on the
swift availability of innovative medicines to patients and on rewarding
pharmaceutical innovation when medicines are approved for reimbursement.
However, given the complexity of the health technology assessment (HTA)
procedures, it was deemed necessary to find a more differentiated approach for
the time limits; therefore, different time limits are proposed, depending on
whether the medicinal products are subject to health technology assessment
(90/180 days) or not (60/120 days).

The impact assessment report and its
executive summary are available at:          
http://ec.europa.eu/governance/impact/ia_carried_out/cia_2012_en.htm.

3.           LEGAL ELEMENTS OF THE PROPOSAL

·
Legal basis and subsidiarity

The main objective of Directive 89/105/EEC
is to facilitate the functioning of the internal market for medicinal products.
The legal basis is therefore Article 114 of the Treaty on the Functioning of
the European Union.

The existing Directive has as its
underlying principle the idea of minimum interference in the organisation by
Member States of their domestic social security policies.[6] This fundamental principle is
maintained in the proposal. The proposed requirements to ensure timely and
transparent decisions carefully balance the obligation to preserve the
competences of Member States in the field of public health against the
necessity to guarantee the effectiveness of the Directive in meeting its
internal market objectives. In order to respect the responsibilities of the
Member States under the Treaty, the proposal does not provide for the
approximation of national pricing and reimbursement measures, nor does it
restrain the ability of Member States to freely determine the prices of
medicines and the conditions of their public funding on the basis of the
criteria they choose. The impact assessment report explains in further detail
how the subsidiarity and proportionality principles have been taken into
account in the proposal.

·
Overview of the main legal elements

The proposal maintains the core principles
of the existing Directive but also puts forward a comprehensive adaptation of
its legal provisions based on the following key elements:

–
Clarification of the scope of the Directive: the transparency requirements apply to all pricing and
reimbursement measures understood in a broad sense, including “demand side”
measures to control or promote the prescription of specific medicines.
Nevertheless, measures involving public procurement and voluntary contractual
agreements with individual companies are excluded from the scope of the
Directive in order to avoid interference with other bodies of law.

–
Comprehensive coverage of national measures
and legal clarity: the provisions of the Directive
are reworded in accordance with general principles (rather than on the basis of
specific national procedures) and incorporate the case-law of the Court of
Justice. Several key provisions are clarified and updated to avoid
interpretation controversies. In particular, it is made clear that the time
limits for pricing and reimbursement decisions include all procedural steps
leading to the decision, including health technology assessments where
applicable.

–
Adaptation of the time limits for pricing
and reimbursement decisions: the time limits
applicable to generic medicines are reduced to 30/60 15/30
days when the reference product has already been priced and included in the
health insurance system. The time limits applicable to all other medicinal
products are reduced to 60/120 days. However, in cases where national
authorities subject medicinal products to health technology assessment
procedures in order to assess the relative efficacy or the short- and long-term
effectiveness, as an integral part of their decision-making process, the
time-limits shall be 90/180 days.

–
Non-interference of patent and safety issues
with pricing and reimbursement procedures: the
proposal clarifies that intellectual property rights should not interfere with
pricing and reimbursement procedures, as is already the case for marketing
authorisation procedures. In addition, elements already assessed in the
framework of the marketing authorisation process (quality, safety and efficacy,
including bioequivalence) may not be reassessed in the framework of pricing and
reimbursement procedures.

–
Dialogue and enforcement tools: different instruments are put in place to facilitate dialogue on
the implementation of the Directive and to ensure its effective enforcement
(consultation on draft measures at national level and pre-notification to the
Commission, the creation of a remedies procedure in case of non-compliance with
the time-limits related to the inclusion of medicinal products in health
insurance systems).

·
Repeal of Directive 89/105/EEC

The amendments proposed to Directive
89/105/EEC are substantial and cover all major provisions currently in force.
For the sake of legal clarity, and in accordance with the principle of better
regulation, the adoption of the proposal will lead to the repeal of existing legislation.
However, the effects of Article 10 of Directive
89/105/EEC shall be maintained.

No correlation table is foreseen as the
existing EU legislation referring to Directive 89/105/EEC does so in a general
way without pointing to specific provisions of the Directive.

4.           BUDGETARY IMPLICATION [where
necessary]

The Commission's proposal has no impact on
the European Union budget beyond what is already foreseen for the years to come
in the Multiannual Financial Framework. The details of the financial resources
are indicated in the Legislative Financial statement.

5.           TRANSPOSITION

The notification of the Member States'
transposition measures must be accompanied by correlation tables explaining the
relationship between the components of a directive and
the corresponding parts of national transposition instruments. This is
necessary due to:

·
The complexity of the Directive, which does not
touch upon the substance but only lays down minimum procedural requirements to
ensure the transparency of the measures regulating the
prices of medicinal products for human use and their inclusion in the scope of
public health insurance systems.

·
The complexity of the transposition process due
to the difficulties related to the interpretation of the Directive. The
application of a set of procedural rules to the complicated architecture of the
pricing and reimbursement systems is not always easy and straightforward.

·
The constant evolution of national measures on
pricing and reimbursement in view of controlling pharmaceutical expenditure,
which makes it difficult to monitor the implementation process.

Therefore, the obligation to communicate
correlation tables will facilitate the implementation process.

6.           ADDITIONAL INFORMATION

The proposed act concerns an EEA matter and should therefore
extend to the European Economic Area.

The proposal for a Directive repealing the Council
Directive 89/105/EEC was adopted by the Commission on 1 March 2012.

The European Economic and Social Committee Opinion was
adopted on 12 July 2012.

Negotiations in the Council Working
Party on Pharmaceuticals and Medical Devices proved to be difficult, given the
politically sensitive nature of the file. Main concerns of the Member States were
related to: the principle of subsidiarity; the remedies procedure (Article 8);
the creation of a system of pre-notification of draft national measures to the
Commission (Article 16); shortening of the time limits for taking decisions on
pricing of medicines and their inclusion in the scope of health insurance
systems (Articles 3, 4, 5, 7); the distinction between originator medicinal
products subject to HTA and those not subject to HTA (Articles 3, 7); the obligation
to consult the interested parties (Article 15).

The
European Parliament adopted its position in 1st reading on 6
February 2013 with 559 votes in favour, 54 against and 72 abstentions. The
European Parliament put forward amendments which provide
a pragmatic compromise: while maintaining the substance of the Commission
proposal, they also take into consideration the concerns expressed by the
Member States.

As the result of the vote in Plenary and taking into
consideration the position of the Member States in the Council, the Commission
decided to amend its Proposal. The amendments of the
European Parliament voted in Plenary have been duly taken into account. The Commission accepted or accepted in principle a
large number of the amendments: 50 were acceptable
(16 as such and 34 acceptable in principle, even if, a few of them were
acceptable only in part) and only 7 were unacceptable. These 7 amendments were
unacceptable because they represented a step backwards compared to the existing
Directive, because they would have introduced legal uncertainty, or they would
have gone beyond EU competences.

2012/0035 (COD)

Amended proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

on the transparency of measures regulating
the prices of medicinal products for human use and their inclusion in the scope
of public health insurance systems

THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the
Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the
European Commission,

After transmission of the draft legislative
act to the national Parliaments,

Having regard to the opinion of the
European Economic and Social Committee,[7]

After consulting the European Data
Protection Supervisor,

Acting in accordance with the ordinary
legislative procedure,

Whereas:

(1)       Council Directive
89/105/EEC of 21 December 1988 relating to the transparency of measures
regulating the pricing of medicinal products for human use and their inclusion
in the scope of national health insurance systems[8] was adopted so as to remove
distortions to intra-Community trade in medicinal products.

(2)       In order to take into
account the evolution of the pharmaceutical market and of national policies to
control public expenditure on medicines medicinal products,
substantive changes are necessary to all major provisions of Directive
89/105/EEC. Therefore, in the interest of clarity, Directive 89/105/EEC should
be replaced.

(3)       Union
legislation provides a harmonised framework for the authorisation of medicinal
products for human use. According to Directive
2001/83/EC of the European Parliament and of the Council of 6 November 2001 on
the Community code relating to medicinal products for human use,[9] medicinal products may
be placed on the market in the Union only after they have received a marketing
authorisation based on the evaluation of their quality, safety and efficacy.

(4)       Member States have been
confronted to a steady rise in pharmaceutical expenditure over the last
decades, leading to the adoption of increasingly innovative and complex
policies to manage the consumption of medicines medicinal
products in the framework of their public health insurance systems.
In particular, Member States’ authorities have implemented a broad range of
measures to control the prescription of medicinal products
es, to regulate their prices or to establish the conditions of their public
funding. Such measures mainly aim at promoting public health for all
citizens by ensuring the availability of
adequate supplies of medicinal products at reasonable costs, while ensuring the
financial stability of public health insurance systems.

(5)       Disparities
in national measures may hinder or distort intra-Union trade in medicinal
products and distort competition, thereby directly affecting the functioning of
the internal market in medicinal products.

(6)       In order to reduce the
effects of the disparities on the internal market, national measures should
comply with minimum procedural requirements enabling the parties concerned to
verify that those measures do not constitute quantitative restrictions on
imports or exports or measures having equivalent effect thereto. Those
minimum procedural requirements should also ensure legal certainty and
transparency for all the parties involved in the process of pricing of
medicinal products and inclusion in the health insurance systems, while
promoting the production of medicinal products, accelerating the entry into the
market of generic medicinal products and encouraging research and development
of new medicinal products. However, those requirements should not affect
the policies of those Member States which rely primarily upon free competition
to determine the price of medicinal products. They also should not affect
national policies on price setting and on the determination of social security
schemes, except as far as it is necessary to attain transparency within the
meaning of this Directive and to ensure the functioning of the internal market.

(7)       In order to ensure the
effectiveness of the internal market in medicinal products, this Directive
should apply to all medicinal products for human use within the meaning of
Directive 2001/83/EC.

(8)       Due to diversity of
national measures managing the consumption of medicines, regulating their
prices or establishing the conditions of their public funding it is necessary
to clarify Directive 89/105/EEC. In particular this Directive should cover all
types of measures devised by Member States and susceptible to impact the
internal market. Since the adoption of Directive 89/105/EEC, the pricing and
reimbursement procedures have evolved and have become more complex. While some
Member States have interpreted the scope of Directive 89/105/EEC restrictively,
the Court of Justice ruled that those pricing and reimbursement procedures fall
within the scope of Directive 89/105/EEC given the objectives of that Directive
and the need to ensure its effectiveness. Therefore, this Directive should
reflect the developments in national pricing and reimbursement policies. Given
that specific rules and procedures exist in the area of public procurement and
voluntary contractual agreements, national measures involving public
procurement and voluntary contractual agreements should be excluded from the
scope of this Directive.

(9)       Competent authorities and
marketing authorisation holders increasingly engage in voluntary contractual
agreements to provide patients with access to innovative treatments. In
particular, those agreements allow the inclusion of a medicinal product in the
scope of the health insurance systems while at the same time addressing the evidentiary
uncertainties relating to the relative efficacy and/or effectiveness of a
specific medicinal product by monitoring the elements agreed upfront and for a
defined period of time. The delay in defining the terms and conditions of such
voluntary contractual agreements often exceeds the time limits set in this
Directive and justifies the exclusion of such agreements from its scope. Those
agreements should effectively facilitate or enable patients' access to
innovative medicinal products, should remain voluntary and should not affect
the right of the marketing authorisation holder to submit an application for
the inclusion of a medicinal product in the health insurance system pursuant to
this Directive.

(10)     Any measure taken
by the Member State to regulate, either directly or indirectly, the
prices of medicinal products, as well as any measure to determine their
coverage by public health insurance systems should be based on transparent
objective and verifiable criteria that are independent from the origin of
the product and should provide adequate legal remedies, including judicial
remedies, in accordance with national procedures, to
affected companies. These requirements should equally apply to national,
regional or local measures to control or promote the prescription of specific
medicinal products as such measures also determine their effective coverage by
health insurance systems.

(11)     The Union's support for
cooperation on health technology assessment (hereinafter “HTA”) in accordance
with Article 15 of Directive 2011/24/EU of the European Parliament and of the
Council of 9 March 2011 on the application of patients' rights in cross-border
healthcare[10]
aims to optimise and coordinate HTA methodologies which should ultimately also
reduce delays in pricing and reimbursement procedures of medicinal products for
which Member States use HTA as part of their decision-making process. HTA
includes, in particular, information on the relative efficacy as well as on the
short-term and long-term effectiveness, where appropriate, of health
technologies, also taking into account broader economic and social benefits or
cost-effectiveness of the assessed medicinal product, in accordance with the
methodology of the competent authorities. HTA is a multidisciplinary process
that summarises information about the medical, social, economic and ethical
aspects relating to the use of health technology in a systematic, transparent,
unbiased and robust manner. Its aim is to contribute to the formulation of
safe, effective, health policies that are patient-focused and that seek to
achieve best value.

(12)     Applications to approve the
price of a medicinal product or to determine its coverage by the health
insurance system should not delay the placing on the market of that product
beyond what is necessary. It is therefore desirable that this Directive sets
out mandatory time limits within which national decisions should be made. In
order to be effective, the prescribed time periods should run from the receipt
of an application until the entry into force of the corresponding decision.
They should include all expert evaluations, including health technology
assessments where applicable, and all administrative steps required for the
decision to be adopted and take legal effect.

(13)     In order to facilitate
compliance with the time limits set in this Directive, it may be useful for
applicants of a marketing authorisation to start informal negotiations for
price approval or for inclusion of a medicinal product in the public health insurance
systems already before the marketing authorisation is granted. To this end,
Member States should have the possibility to allow such applicants to submit a
request for informal negotiations for price approval of a medicinal product or
for its inclusion in the health insurance systems after the scientific
assessment is finalised by the Committee for Medicinal Products for Human Use or
by the national competent authority in charge of the marketing authorisation
procedure, as appropriate. In such cases the time limits for decisions on the
price of a medicinal product or its inclusion in the health insurance system
should run from the formal application for pricing or inclusion in the health
insurance systems after the granting of the marketing authorisation.

(14)     The time-limits for the
inclusion of medicinal products in the health insurance systems set out in
Directive 89/105/EEC are mandatory as clarified by the case-law of the Court of
Justice. Experience has shown that those time limits are not always respected
and that there is need to ensure legal certainty and improve the procedural
rules related to the inclusion of medicinal products in the scope of health
insurance system. Therefore, an effective and rapid remedies procedure should
be put in place.

(15)     In its Communication
"Executive Summary of the Pharmaceutical Sector Inquiry Report"[11] the Commission demonstrated
that pricing and reimbursement procedures often unnecessarily delay the launch
of generic medicinal products medicines in Union
markets. Approving the price of generic medicinal products and their coverage
by the health insurance system should not require any new or detailed
assessment when the reference product has already been priced and included in
the health insurance system. It is therefore appropriate to lay down shorter
time limits for generic medicinal products in those cases. Same
conditions might apply where appropriate to biosimilar medicinal products.

(16)     The judicial remedies
available in the Member States have played a limited role in ensuring
compliance with the time limits due to the often lengthy procedures in national
jurisdictions, which deter affected companies from initiating legal action.
Therefore, effective mechanisms are necessary to ensure swift
infringement resolution besides the judicial proceedings if necessary so as to
control and enforce compliance with the time limits for pricing and
reimbursement decisions. To this end, Member States should have the
possibility to designate an existing administrative body.

(17)     The quality, safety and
efficacy of medicinal products, including the bioequivalence of generic medicinal
products or the biosimilarity of biosimilar medicinal products with
the reference product, are ascertained in the framework of marketing authorisation
procedures. In the framework of pricing and reimbursement procedures, the
competent authorities Member States should therefore not
re-assess the elements on which the marketing authorisation is based,
including the quality, safety, efficacy or bioequivalence or
biosimilarity of the medicinal product which have been
already assessed during the marketing authorisation process. Similarly, in the
case of orphan medicinal products, the competent authorities should not
re-assess the criteria of the orphan designation. However, competent
authorities should have full access to the data used by the authorities
responsible for granting the marketing authorisation of a medicinal product as
well as the possibility of using or generating additional relevant data for the
purpose of assessing a medicinal product in the context of its inclusion in the
scope of the public health insurance system.

(18)     The non-reassessment of the
elements on which the marketing authorisation is based within the framework of
pricing and reimbursement procedures should not, however, prevent the competent
authorities from requesting, accessing and using data generated during the
marketing authorisation process for the purpose of HTA. Data sharing between
the competent authorities responsible for marketing authorisation and for
pricing and reimbursement should be possible at national level if such sharing
exists. The competent authorities should also be able to use available data or
generate additional relevant data for health technology assessment purpose.

(19)     In
accordance with Directive 2001/83/EC, intellectual property rights do not
provide a valid ground to refuse, suspend or revoke a marketing authorisation.
By the same token, applications, decision-making procedures and decisions to regulate
the prices of medicinal products or to determine their coverage by health
insurance systems should be considered administrative procedures which, as
such, are independent from the enforcement of intellectual property rights. The
national authorities in charge of those procedures, when examining an
application with respect to a generic or
biosimilar medicinal product, should not
request information concerning the patent status of the reference medicinal
product and should not examine the validity of an alleged violation of
intellectual property rights should the generic or biosimilar medicinal product
be manufactured or placed on the market subsequently to their decision.
Consequently, intellectual property issues should neither interfere with nor
delay pricing and reimbursement procedures in the Member States.

(20)     The Commission and the Member States might investigate possibilities to co-operate in the view of setting up and
maintaining price information database on medicinal products and relevant conditions
so as to provide a Union-wide added value in terms of price transparency while
respecting the Member States’ competences in this field.

(21)     In order to ensure the transparency,
integrity and independence of the decision-making process within the national
competent authorities, the names of experts participating in the bodies
responsible for pricing and reimbursement decisions, together with their
declarations of interest and the procedural steps leading to pricing and
reimbursement decisions should be disclosed to the public.

(22)     Member States have
frequently amended their health insurance schemes or adopted new measures
falling within the scope of Directive 89/105/EEC. It is therefore necessary to
establish an information mechanism mechanisms
intended, on the one hand, to ensure the consultation of all
interested stakeholders including civil society organisations, such as
patient and consumer groups and, on the other hand, to
facilitate preventive dialogue with the Commission as regards the application
of this Directive. Since the objective of the action to be taken, namely
providing minimal transparency rules to ensure the functioning of the internal
market, cannot be sufficiently achieved by the Member States, as the notion of
transparency of national measures is understood and applied differently in each
Member State, and can therefore, by reason of the scale of the action be better
achieved at Union level, the Union may adopt measures, in accordance with the
principle of subsidiarity as set out in Article 5 of the Treaty on European
Union. In accordance with the principle of proportionality, as set out in that
Article, this Directive does not go beyond what is necessary in order to
achieve that objective.

(23)     In accordance with the
Joint Political Declaration of Member States and the Commission on explanatory
documents of 28 September 2011, Member States have undertaken to accompany, in
justified cases, the notification of their transposition measures with one or
more documents explaining the relationship between the components of a
directive and the corresponding parts of national transposition instruments.
With regard to this Directive, the legislator considers the transmission of
such documents to be justified.

HAVE ADOPTED THIS DIRECTIVE:

Chapter I

Scope and definitions

Article 1

Subject matter and scope

1.           Member States shall ensure
that any national, regional or local measure, whether laid down by law,
regulation or administrative action, to control the prices of medicinal
products for human use or to determine the range of medicinal products covered
by public health insurance systems, including the extent and conditions of
their coverage, complies with the requirements of this Directive. Member
States shall also ensure that the national procedures related to the pricing of
medicinal products and their inclusion in the health insurance systems are not
duplicated at regional or local level in their respective territories.

2.           This Directive shall not
apply to the following:

(a)
voluntary contractual agreements which
are concluded between competent authorities and the marketing authorisation
holder for a medicinal product which is not mandatory nor represents the only
possibility for the medicinal product to be included in the health insurance
systems, and which aims to include a medicinal product under the scope of a
health insurance system while monitoring elements are agreed upfront among both
parties relating to the effectiveness and/or relative efficacy of the given
medicinal product, with a view to enabling the effective provision of that
medicine to patients under specific conditions and during an agreed period of
time.

concluded between public
authorities and the holder of a marketing authorisation for a medicinal product
that have as their object to enable the effective provision of this medicine to
patients under specific conditions;

(b)
national measures intended to determine the
prices or the coverage of medicinal products by public health insurance systems
which are subject to national or Union legislation on public procurement, in
particular Council Directive 89/665/EEC,[12]
Council Directive 92/13/EEC[13]
and Directive 2004/18/EC of the European Parliament and of the Council.[14]

The provisions of this Directive shall apply to
measures intended to determine which medicinal products may be included in
contractual agreements or public procurement procedures. In accordance
with Union and national law regarding business confidentiality, information
regarding the name of the medicinal product and the name of the marketing
authorisation holder included in contractual agreements or public procurement
procedures shall be made publicly available once those agreements or procedures
are concluded.

3.           Nothing in this Directive
shall permit the placing on the market of a medicinal product which has not
received marketing authorisation as provided for in Article 6 of Directive 2001/83/EC.

This Directive shall be without
prejudice to the marketing authorisation relating to a medicinal product
granted in accordance with the procedure referred to in Article 6 of Directive
2001/83/EC and Article 3 of Regulation (EC) No 726/2004 of the European
Parliament and of the Council. [15]

Article 2

Definitions

For the purposes of this Directive, the
following definitions apply:

(1)
“medicinal product” means a medicinal product as
defined in Article 1 of Directive 2001/83/EC;

(2)
“reference medicinal product” means a reference
medicinal product as defined in point (a) of Article 10(2) of Directive
2001/83/EC;

(3)
“generic medicinal product” means a generic
medicinal product as defined in point (b) of Article 10(2) of Directive
2001/83/EC;

(4)
“biosimilar medicinal product”
means biological medicinal product which is similar to a reference biological
medicinal product;

(5)
“health technology” means a health technology as
defined in point (l) of Article 3 of Directive 2011/24/EU of the European
Parliament and of the Council[16];

(6)
“health technology assessment” means an
assessment which as a minimum includes of the
assessment of the relative efficacy or of the short- and long-term
effectiveness of the medicinal product compared to other health technologies or
interventions in use for treating the associated condition.

Chapter II

Pricing of medicinal products

Article 3

Price approval

1.           Paragraphs 2 to 9 shall
apply if the marketing of a medicinal product is permitted only after the
competent authorities of the Member State concerned have approved the price of
the product.

2.           Member States shall ensure
that an application to approve the price of the product can be introduced by
the marketing authorisation holder at any point in time. The competent authorities shall provide the applicant with an
official acknowledgement of receipt of the formal application for pricing within
10 days of its receipt.

Member States may provide the
possibility to the applicant of a marketing authorisation to submit a request
for informal negotiations on price approval when the Committee for Medicinal
Products for Human Use established by Article 5 of Regulation (EC) No 726/2004
or the national competent authority has issued an opinion in favour of the
granting of a marketing authorisation for the medicinal product concerned.

3.           Member States shall ensure
that a decision on the price which may be charged for the medicinal product
concerned is adopted and communicated to the applicant within 60 90
days of the receipt of an application submitted, in accordance with
the requirements laid down in the Member State concerned, by the holder of a
marketing authorisation. However, with respect to medicinal products for
which Member States use health technology assessment as part of their
decision-making process, the time-limit shall be 90 days. With respect to
generic medicinal products, that time limit shall be 30 15
days, provided that the price of the reference medicinal product has been
approved by the competent authorities.

Where Member States decide to include
health technology assessment as part of their decision-making process on the
pricing of medicinal products, such assessment shall be carried out within the
time limits set out in the first subparagraph.

4.           Member States shall
establish in detail the particulars and documents to be submitted by the
applicant.

5.           If the information
supporting the application is inadequate, the competent authorities shall
forthwith notify the applicant of the detailed additional information required
and take their final decision within 90 60 days of
receipt of this additional information. However, with respect to medicines
for which Member States use health technology assessment as part of their
decision-making process, the time-limit shall be 90 days. With respect to
generic medicinal products, that time limit shall be 3015
days, provided that the price of the reference medicinal product has been
approved by the competent authorities. Member States shall not request any
additional information which is not explicitly required under national
legislation or administrative guidelines.

6.           In the absence of a
decision within the relevant time limit set out in paragraphs 3 and 5, the
applicant shall be entitled to market the product at the price proposed.

7.           If the competent
authorities decide not to permit the marketing of the medicinal product
concerned at the price proposed by the applicant, the decision shall contain a
statement of reasons based on objective and verifiable criteria, including any
evaluation, expert opinion or recommendation on which it is based. The
applicant shall be informed of all remedies available, including judicial
remedies, and of the time limits for applying for such remedies.

8.           Member States shall
publish in an appropriate publication and communicate to the Commission the
criteria which the competent authorities must take into account when approving
the prices of medicinal products. Member States shall make publicly
available the information on those criteria and decision-making bodies at
national or regional level.

9.           If the competent
authorities decide to reduce the price of a specific named medicinal product on
their own initiative, the decision shall contain a statement of reasons based
on objective and verifiable criteria, including any evaluation, expert opinion
or recommendation on which it is based. The decision shall be communicated to
the holder of the marketing authorisation, who shall be informed of all
remedies available, including judicial remedies, and of the time limits for
applying for such remedies. The decision and summary of the statement
of reasons shall be made publicly available by the competent authorities
without delay, after deletion of any information of a
commercially confidential nature.

Article 4

Price increase

1.           Without prejudice to
Article 5, paragraphs (2) to (6) shall apply if an increase in the price of a
medicinal product is permitted only after prior approval has been obtained from
the competent authorities.

2.           Member States shall ensure
that an application to increase the price of the product can be submitted by
the marketing authorisation holder in accordance with national law
at any point in time. The competent authorities shall provide the applicant
with an official acknowledgement of receipt of the application
within 10 days of its receipt.

3.           Member
States shall ensure that a decision to approve
or reject on an application
submitted in accordance with the requirements laid down in the Member State
concerned, by a marketing authorisation holder to increase the price of a
medicinal product is adopted and communicated to the applicant within 90 60 days of its
receipt.

In case of an exceptional number of applications,
the time limit set out in this paragraph may be extended once only for a
further 60 days. The applicant shall be notified of such an extension before
the expiry of the time limit set out in this paragraph.

4.           Member States shall
establish in detail the particulars and documents to be submitted by the
applicant.

The applicant shall furnish the competent
authorities with adequate information, including details of those events
intervening since the price of the medicinal product was last determined which
in his opinion justify the price increase requested. If
the information supporting the application is inadequate, the competent
authorities shall forthwith notify the applicant of the detailed additional
information required and take their final decision within 90
60 days of receipt of this additional information. Member States shall
not request any additional information which is not explicitly required under
national legislation or administrative guidelines.

5.           In
the absence of a decision within the relevant time limit referred to in
paragraphs 3 and 4, the applicant shall be entitled to apply the price increase
requested.

6.           If
the competent authorities decide not to permit the whole or part of the price
increase requested, the decision shall contain a statement of reasons based on
objective and verifiable criteria and the applicant shall be informed of all
remedies available, including judicial remedies, and of the time limits for
applying for such remedies.

Article 5

Price
freeze and price reduction

1.           In the event of a price
freeze or price reduction imposed on all medicinal products or on certain
categories of medicinal products by the competent authorities of a Member
State, that Member State shall publish a statement of reasons for its decision
based on objective and verifiable criteria, including, if applicable, a
justification of the categories of products subject to the price freeze or
price reduction. Once a year Member States shall
assess whether the price freeze or the price reduction is still justified
taking into account the macro-economic conditions and adopt necessary changes
where appropriate.

2.           Marketing authorisation
holders may apply for a derogation from a price freeze or price reduction if
this is justified by particular reasons. The application shall contain an
adequate statement of reasons. Member States shall ensure that applications for
a derogation can be introduced by the marketing authorisation holder at any
point in time. The competent authorities shall provide the applicant with an
official acknowledgement of receipt of the formal applicationfor
inclusion of the medicinal product in the health insurance system within 10
days of its receipt.

3.           Member States shall ensure
that a reasoned decision on an application referred to in paragraph 2 is
adopted and communicated to the applicant within 90 60
days of the receipt of the application. If the information supporting the
application is inadequate, the competent authorities shall forthwith notify the
applicant of the detailed additional information required and take their final
decision within 90 60 days of receipt of this
additional information. If the derogation is granted, the competent authorities
shall forthwith publish an announcement of the price increase allowed.

If there is an exceptional number of
applications, the relevant time limit set out in paragraph 3 may be extended
once only for a further 60 days. The applicant shall be notified of such
extension before the expiry of the time limit set out in paragraph 3.

Article 6

Controls
on profits

Where a Member State adopts a system
of direct or indirect controls on the profitability of persons responsible for
placing medicinal products on the market, the Member State concerned shall
publish the following information in an appropriate publication and communicate
it to the Commission:

(a)
the method or methods used in the Member State concerned to define profitability: return on sales and/or return on capital;

(b)
the range of target profit currently permitted
to persons responsible for placing medicinal products on the market in the Member State concerned;

(c)
the criteria according to which target rates of
profit are accorded to an individual responsible for placing medicinal products
on the market, together with the criteria according to which they will be
allowed to retain profits above their targets in the Member State concerned;

(d)
the maximum percentage profit which any person
responsible for placing medicinal products on the market is allowed to retain
above his target in the Member State concerned.

The information referred to in the
first subparagraph shall be updated once a year or when significant changes are
made.

Where, in addition to operating a system of
direct or indirect controls on profits, a Member State operates a system of
controls on the prices of certain types of medicinal products which are
excluded from the scope of the profit control scheme, Articles 3, 4 and 5
shall, where relevant, apply to such price controls. However, those Articles
shall not apply where the normal operation of a system of direct or indirect
controls on profits results exceptionally in a price being fixed for an
individual medicinal product.

Chapter III

Coverage of medicinal products by public
health insurance systems

Article 7

Inclusion of medicinal products in
health insurance systems

1.           Paragraphs 2 to 8
9 shall apply if a medicinal product is covered by the public health
insurance system only after the competent authorities have decided to include
the medicinal product concerned in the scope of that system.

2.           Member States shall ensure
that an application to include a medicinal product in the scope of the public
health insurance system can be introduced by the marketing authorisation holder
at any point in time. The competent authorities shall provide the
applicant with an official acknowledgement of receipt of
the application within 10 days of its receipt.

Member States may also provide the
possibility to the applicant of a marketing authorisation to submit a request
for informal negotiations on inclusion of a medicinal product in the scope of
the publisc health insurance systems when the Committee for Medicinal Products
for Human Use established by Article 5 of Regulation (EC) No 726/2004 or the
national competent authority has issued an opinion in favour of the granting of
a marketing authorisation for the medicinal product concerned.

3.           If the public health
insurance system comprises several schemes or categories of coverage, the
marketing authorisation holder shall be entitled to apply for the inclusion of
its product in the scheme or category of its choice. Member
States shall establish in detail the particulars and documents to be submitted
by the applicant.

4.           Member States shall ensure
that a decision on an application to include a medicinal product in the scope
of the public health insurance system, submitted by the marketing authorisation
holder in accordance with the requirements laid down in the Member State
concerned, is adopted and communicated to the applicant within 90
60 days of its receipt. However, with respect to medicinal products
for which Member States use health technology assessment as part of their
decision-making process, the time-limit shall be 90 days. With respect to
generic medicinal products, that time limit shall be 15 30
days, provided that the reference medicinal product has already been included
in the public health insurance system.

Where Member States decide to include
health technology assessment as part of their decision-making process on the
pricing of medicinal products, such assessment shall be carried out within the
time limits set out in the first subparagraph

5.           If the information
supporting the application is inadequate, the competent authorities shall
forthwith notify the applicant of the detailed additional information required
and take their final decision within 90 60 days of
receipt of the additional information. However, with respect to medicinal
products for which Member States use health technology assessment as part of
their decision-making process, the time-limit shall be 90 days. With
respect to generic medicinal products, that time limit shall be 15 30
days, provided that the reference medicinal product has already been included
in the public health insurance system. Member States shall not request any
additional information which is not explicitly required under national
legislation or administrative guidelines.

6.           Irrespective of the
organisation of their internal procedures, Member States shall ensure that the
overall period of time taken by the inclusion procedure set out in paragraph 5
of this Article and the price approval procedure set out in Article 3 does not
exceed 120 180 days. However, with respect to
the medicinal products for which Member States use health technology assessment
as part of their decision-making process, the time limit shall not exceed 180
days. With respect to generic medicinal products, that time limit shall not
exceed 30 60 days, provided that the reference
medicinal product has already been included in the public health insurance
system. Those time-limits may be extended in accordance with paragraph 5 of
this Article or Article 3(5).

7.           Any decision not to
include a medicinal product within the scope of the public health insurance
system shall contain a statement of reasons based upon objective and verifiable
criteria. Any decision to include a medicinal product within the scope of the
public health insurance system shall contain a statement of reasons justifying
the decision, including the extent and conditions of the product’s coverage, on
the basis of objective and verifiable criteria.

The decisions referred to in this paragraph
shall also include any evaluation, expert opinion or recommendation on which
they are based. The applicant shall be informed of all remedies available,
including judicial remedies, and the remedies procedure set out Article 8, of
the time limits for applying for such remedies.

8.           Member States shall
publish in an appropriate publication and communicate to the Commission the
criteria which the competent authorities must take into account when deciding
whether or not to include medicinal products within the scope of the public
health insurance system. Member States shall make publicly available
the information on those criteria and decision-making bodies at national or
regional level.

Article 8

Remedies procedure in case of
non-compliance with the time limits related to the inclusion of medicinal
products in health insurance systems

1.           Member States shall ensure
that effective and rapid remedies procedures are available to the applicant in
case of non-compliance with the time limits set out in Article 7 and are in
accordance with their national law.

2.           For the purposes of the
remedies procedures referred in paragraph 1, Member States may designate a body
and entrust it with the powers to take, at the earliest opportunity and by way
of interlocutory procedures, interim measures with the aim of correcting the
alleged infringement or preventing further damage to the interests concerned.

3.           The body in charge of the remedies
procedures shall be independent of the competent authorities in charge of
controlling the prices of medicinal products or in charge of determining the
range of medicinal products covered by health insurance systems.

4.           Member States shall ensure
that effective and rapid remedies are available to the applicant in case of
non-compliance with the time limits set in Article 7.

5.           For the purposes of the
remedies procedure Member States shall designate a body and entrust it with the
powers to:

(a)
take, at the earliest opportunity and by
way of interlocutory procedures, interim measures with the aim of correcting
the alleged infringement or preventing further damage to the interests
concerned;

(b)
award damages to the applicant in case of
non-compliance with time limits set in Article 7 where damages are claimed,
unless the competent authority may prove that the delay is not imputable to it;

(c)
impose a penalty payment, calculated by
day of delay.

For the purposes of point (c), the penalty
payment shall be calculated depending on the seriousness of the infringement,
its duration, the need to ensure that the penalty itself is a deterrent to
further infringements.

Member States may provide that the body
referred to in the first subparagraph may take into account the probable
consequences of potential measures taken under the present paragraph for all
interests likely to be harmed, as well as the public interest, and may decide
not to take such measures when their negative consequences could exceed their
benefits.

6.           A decision not to grant
interim measure shall not prejudice any other claim of the applicant seeking
such measures.

7.           Member States shall ensure
that decisions taken by bodies responsible for remedies procedures can be
effectively enforced.

8.           The body referred to in
paragraph 2 shall be independent of the competent authorities in charge of
controlling the prices of medicinal products for human use or in charge of
determining the range of medicinal products covered by health insurance
systems.

9.           The body referred to in
paragraph 2 shall state reasons for its decision. Furthermore, where that body
is not judicial in character, provision must be made to guarantee procedures
whereby any allegedly illegal measure taken by the independent body or any
alleged defect in the exercise of powers conferred on it can be subject to
judicial review or review by another body which is a court or tribunal within
the meaning of Article 267 of the Treaty on the Functioning of the European
Union and independent of both the competent authority and the body referred to
in paragraph 2.

The members of the body referred to in
paragraph 2 shall be appointed and leave office under the same conditions as
members of the judiciary as regards the authority responsible for their
appointment, their period of office, and their removal. At least the president
of that body shall have the same legal and professional qualifications as
members of the judiciary. That body shall take its decisions following a
procedure in which both sides are heard, and these decisions shall, by means
determined by each Member State, be legally binding.

Article 9

Exclusion of medicinal products from
health insurance systems

1.           Any decision to exclude a
medicinal product from the scope of the public health insurance system, or to
modify the extent or the conditions of coverage of the product concerned, shall
contain a statement of reasons based on objective and verifiable criteria. Such
decisions shall include any evaluation, expert opinion or recommendation on
which they are based. The applicant shall be informed of all remedies
available, including judicial remedies, and of the time limits for applying for
such remedies.

2.           Any decision to exclude a
category of medicinal products from the scope of the public health insurance
system, or to modify the extent or the conditions of coverage of the category
concerned, shall contain a statement of reasons based on objective and
verifiable criteria and be published in an appropriate publication.

3.           Any decision to exclude a
medicinal product or a category of medicinal products from the scope of the
public health insurance system shall be made publicly available, together with
a summary of the statement of reasons, after deletion
of any information of a commercially confidential nature.

Article 10

Classification of medicinal products in
view of their inclusion in health insurance systems

1.           Paragraphs 2, 3 and 4
shall apply where medicinal products are grouped or classified according to
therapeutic or other criteria for the purpose of their inclusion within the
scope of the public health insurance system.

2.           Member States shall
publish in an appropriate publication and communicate to the Commission the
objective and verifiable criteria according to which medicinal products are
classified in view of their inclusion in the public health insurance system.

3.           For the medicinal products
subject to such grouping or classification, Member States shall publish in an
appropriate publication and communicate to the Commission the methodologies
used to determine the extent or conditions of their inclusion in the public
health insurance system.

4.           At the request of the
holder of a marketing authorisation, the competent authorities shall specify
the objective data on the basis of which they have determined the arrangements
of coverage for their medicinal product, in application of the criteria and
methodologies referred to in paragraphs 2 and 3. In such a case, the competent
authorities shall also inform the marketing authorisation holder of all
remedies available, including judicial remedies, and of the time limits for
applying for such remedies.

Article 11

Measures to control or promote the
prescription of specific medicinal products

1.           Paragraphs 2, 3 and 4
shall apply where a Member State adopts measures intended to control or promote
the prescription of specific named medicinal products.

2.           Measures referred to in
paragraph 1 shall be based on objective and verifiable criteria.

3.           Measures referred to in
paragraph 1, including any evaluation, expert opinion or recommendation on
which they are based, shall be published in an appropriate publication and
made available to the public.

4.           At the request of the
holder of a marketing authorisation whose interests or legal position are
affected by the measures referred to in paragraph 1, the competent authorities
shall specify the objective data and criteria on the basis of which these
measures have been taken with respect to its medicinal product. In such a case,
the competent authorities shall also inform the marketing authorisation holder
of all remedies available, including judicial remedies, and of the time limits
for applying for such remedies.

Chapter IV

Specific requirements

Article 12

Effectiveness of the time limits

1.           The time limits laid down
in Articles 3, 4, 5 and 7 shall be construed as the period between the receipt
of an application or additional information, as the case may be, and the
effective entry into force of the corresponding decision. All expert evaluations
and administrative steps necessary for taking the decision and bringing it into
effect shall be carried out within the prescribed time limits.

2.           If the decision making
process involves negotiations between the marketing authorisation holder and
the competent authority, provided that it is agreed by both parties, the time
limits laid down in Articles 3, 4, 5 and 7 shall be suspended from the time the
competent authority communicates its proposals to the marketing authorisation
holder until the competent authority receives the response to its proposals
from the marketing authorisation holder. Member States shall make available to
the public the practical modalities for such suspension.

Article 13

Additional
proof of quality, safety, efficacy or bioequivalence

1.           In the framework of
pricing and reimbursement decisions, Member States shall not re-assess the
elements on which the marketing authorisation is based, including the the
quality, safety, efficacy, or bioequivalence, or biosimilarity
of the medicinal product or the criteria for orphan designation which
have already been assessed during the marketing authorisation procedure.

2.           Paragraph 1 shall be
without prejudice to the right of the competent authorities to request and have
full access to data generated during the marketing authorisation process for
the purpose of health technology assessment, so that they can assess the
relative efficacy as well as the short- and long-term effectiveness, where appropriate,
of a medicinal product.

3.           The competent authorities
shall also be able to use the available data or generate additional relevant
data for the purpose of health technology assessment.

Article 14

Non interference of intellectual
property rights

1.           Applications,
decision-making procedures and decisions to regulate the prices of medicinal
products in accordance with Article 3 or to determine their inclusion within
the scope of public health insurance systems in accordance with Articles 7 and
9 shall be considered by Member States as administrative procedures which, as
such, are independent from the enforcement of intellectual property rights.

2.           The protection of
intellectual property rights shall not be a valid ground to refuse, suspend or
revoke decisions relating to the price of a medicinal product or its inclusion
within the public health insurance system.

3.           Paragraphs 1 and 2 shall
apply without prejudice to the Union and national legislation relating to the
protection of intellectual property.

Chapter V

Transparency mechanisms

Article 15

Consultation of interested parties

Where a Member State intends to adopt or
amend any legislative measure falling within the scope of
this Directive, it shall give civil society organisations, including
patient and consumer groups, and other interested
parties, the opportunity to comment on the draft measure within a reasonable
period. The competent authorities shall publish the rules applicable to
consultations. The results of consultations shall be made publicly available,
with the exception of confidential information in accordance with Union and national legislation regarding business confidentiality.

Article 16

Transparency of decision-making bodies
and prices

1.           Member States shall ensure
that the competent authorities controlling the prices of medicinal products or
determining the coverage of medicinal products by public health insurance
systems make publicly available a regularly updated list of the members of
their decision-making bodies, together with their declarations of interest.

2.           Paragraph 1 shall also
apply to the body referred to in Article 8(2).

Article 16

Notification of draft national
measures

1.           Where Member States intend
to adopt or amend any measure falling within the scope of this Directive, they
shall immediately communicate to the Commission the draft measure envisaged,
together with the reasoning on which the measure is based.

2.           Where appropriate, Member
States shall simultaneously communicate the texts of
the basic legislative or regulatory provisions principally and directly
concerned, if knowledge of such texts is necessary to assess the implications
of the measure proposed.

3.           Member
States shall communicate the draft measure referred to in paragraph 1 again if
they make changes to the draft that have the effect of significantly altering
its scope or substance, or shortening the timetable originally envisaged for
implementation.

4.           The
Commission may send its observations to the Member State which has communicated
the draft measure within three months.

The observations of the Commission shall be
taken into account as far as possible by the Member State concerned, in
particular if the observations indicate that the draft measure may be
incompatible with Union law.

5.           When the Member State concerned definitively adopts the draft measure, it shall communicate the final
text to the Commission without delay. If observations have been made by the
Commission in accordance with paragraph 4, this communication shall be
accompanied by a report on the actions taken in response to the observations of
the Commission.

Article 17

Report on the implementation of the time
limits

1.           By 31 January of [...] [insert
a date - the year following the date referred to in the first subparagraph of
Article 18(1)], and by 31 January and 1 July of every year thereafter,
Member States shall communicate to the Commission and publish in an appropriate
publication a detailed report providing the following information:

(a)
the number of applications received in
accordance with Articles 3, 4 and 7 during the preceding year;

(b)
the amount of time taken to issue a decision on
each of the applications received in accordance with Articles 3, 4, and 7.

(c)
an analysis of the main reasons for delays, if
any, together with recommendations to bring decision-making processes into line
with the time limits laid down in this Directive.

For the purposes of point (a) of the first
subparagraph, a distinction shall be made between generic medicinal products
subject to shorter time limits in accordance with Articles 3, 4 and 7 and other
medicinal products.

For the purposes of point (b) of the first
subparagraph, any suspension of the procedure to request additional information
to the applicant shall be reported with a clear indication of the duration of
the suspension and the detailed reasons for the suspension.

2.           The Commission shall
publish every year six months a report on the
information submitted by Member States according to paragraph 1.

Chapter VI

Final provisions

Article 18

Transposition

1.           Member States shall adopt
and publish, by [last day of the 12th month following publication
of this Directive in the Official journal of the European Union] at the
latest, the laws, regulations and administrative provisions necessary to comply
with this Directive. They shall forthwith communicate to the Commission the
text of those provisions.

They shall apply those provisions from [the day
after the date set out in the first subparagraph.].

When Member States adopt those provisions, they
shall contain a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member States shall
determine how such reference is to be made.

2.           Member States shall
communicate to the Commission the text of the main provisions of national law
which they adopt in the field covered by this Directive.

Article 19

Report on the implementation of this
Directive

1.           Member States shall send a
report to the Commission on the implementation of this Directive by [insert
date - within two years after the date referred to in the second subparagraph
of Article 18(1)] and every three years thereafter.

2.           By [insert date -
within three years after the date referred to in the second subparagraph of
Article 18(1)], the Commission shall submit a report to the European
Parliament and the Council on the implementation of this Directive. The report
may be accompanied by any appropriate proposals.

Article 20

Repeal

Directive 89/105/EEC is repealed from [the
date set out in the second subparagraph of Article 18(1)].

The effects of Article 10 of Directive 89/105/EEC shall be
maintained.

References to the repealed Directive shall
be construed as references to this Directive.

Article 21

Entry into force and application

This Directive shall enter into force on
the twentieth day following that of its publication in the Official Journal
of the European Union.

Article 16 shall apply from [insert
the date - date set out in the second subparagraph of Article 18(1)].

Article 22

Addressees

This
Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament                       For
the Council

The President                                                 The
President

LEGISLATIVE FINANCIAL STATEMENT

1.           FRAMEWORK OF THE PROPOSAL/INITIATIVE

1.1.    Title of the proposal/initiative

1.2.    Policy
area(s) concerned in the ABM/ABB structure

1.3.    Nature
of the proposal/initiative

1.4.    Objective(s)

1.5.    Grounds
for the proposal/initiative

1.6.    Duration
and financial impact

1.7.    Management
method(s) envisaged

2.           MANAGEMENT MEASURES

2.1.    Monitoring
and reporting rules

2.2.    Management
and control system

2.3.    Measures
to prevent fraud and irregularities

3.           ESTIMATED FINANCIAL IMPACT OF THE
PROPOSAL/INITIATIVE

3.1.    Heading(s)
of the multiannual financial framework and expenditure budget line(s) affected

3.2.    Estimated
impact on expenditure

3.2.1. Summary of
estimated impact on expenditure

3.2.2. Estimated impact
on operational appropriations

3.2.3. Estimated impact
on appropriations of an administrative nature

3.2.4. Compatibility
with the current multiannual financial framework

3.2.5. Third-party
participation in financing

3.3.    Estimated impact on revenue

LEGISLATIVE FINANCIAL STATEMENT

1.           FRAMEWORK OF THE PROPOSAL/INITIATIVE

1.1.        Title of the
proposal/initiative

Proposal for a Directive of the European Parliament and of the
Council relating to the transparency of measures regulating the prices of
medicinal products for human use and their inclusion in the scope of public
health insurance systems (Repealing Directive 89/105/EEC)

1.2.        Policy area(s) concerned
in the ABM/ABB structure[17]

Title 02 – Enterprise

1.3.        Nature of the
proposal/initiative

ý The proposal/initiative relates to the
extension of an existing action

1.4.        Objectives

1.4.1.     The Commission's
multiannual strategic objective(s) targeted by the proposal/initiative

1a. Competitiveness for growth and employment

1.4.2.     Specific objective(s) and
ABM/ABB activity(ies) concerned

Specific objective No.1.

To continually develop existing internal market acquis and
propose new legislative or non-legislative action whenever appropriate

ABM/ABB activity(ies) concerned

Chapter 02 03: Internal market for goods and sectoral policies

1.4.3.     Expected result(s) and
impact

Specify the
effects which the proposal/initiative should have on the beneficiaries/groups
targeted.

The proposal provides for a comprehensive update of
Directive 89/105/EEC in view of ensuring the transparency of national measures
regulating the prices of medicinal products for human use and their inclusion
in the scope of social security systems. The existing directive has become
outdated and difficult to enforce due to the evolution of the pharmaceutical
market in the last twenty years and to the multiplication of national measures
to contain growing pharmaceutical costs. The proposal aims at avoiding barriers
to the free movement of goods prohibited by the EU Treaty, while respecting the
responsibilities of the Member States for the organisation of their health
insurance systems. The initiative is expected to:

- Improve legal clarity and certainty for all interested
parties;

- Provide a level playing field for pharmaceutical
companies operating in Europe;

- Facilitate the enforcement of the procedural
obligations incumbent upon Member States.

1.4.4.     Indicators of results and
impact

Specify the indicators for monitoring implementation
of the proposal/initiative.

The proposal consists in a directive to be transposed into national
legislation by the Member States. The first indicator will therefore be the
actual transposition rate by the end of the transposition deadline. Budget is
earmarked in order to ensure the verification of transposition by Member
States.

Effective implementation will be monitored as a second step. The key
objectives pursued by the proposal consist in a) guaranteeing that national
pricing and reimbursement decisions are made within specific time-limits and b)
ensuring the effectiveness of minimal transparency rules for national pricing
and reimbursement measures. Results will be measured against the following
indicators:

1/ Actual timing for pricing and reimbursement decisions in the
Member States (monitoring instrument: mandatory annual reporting by Member
States).

2/ Number of non-compliance cases identified in the Member States
(monitoring instruments: mandatory notification of draft national measures
by national authorities and statistics of infringement procedures).

1.5.        Grounds for the
proposal/initiative

1.5.1.     Requirement(s) to be met in
the short or long term

The text of the proposal essentially requires Member States to
ensure that:

1/ Pricing and reimbursement decisions are made within 60/120
90/180 days. However, with respect to medicines for
which Member States use health technology assessment as part of their
decision-making process, the time-limit shall be days. Furthermore, the
timeframe is reduced to 30/60 15/30 days with
respect to generic medicinal products.

2/ Any measure intended to regulate the prices of medicines, to
manage their consumption or to determine their reimbursement status is adopted
in a transparent manner on the basis of objective and verifiable criteria.

3/ Effective judicial
remedies are available to affected pharmaceutical companies.

1.5.2.     Added value of EU
involvement

National pricing and reimbursement measures have a clear
transnational impact linked, in particular, to the potential disruption they
might cause to the internal market for medicinal products. The proper
functioning of the internal market therefore requires timely and transparent
decisions to be made by Member States. The notion of procedural transparency is
understood differently across the EU so that action by individual Member States
would not provide sufficient guarantees of transparency for economic operators.

1.5.3.     Lessons learned from
similar experiences in the past

In the last twenty years, Directive 89/105/EEC has played a key role
in promoting the transparency of national pricing and reimbursement measures.
However, experience in managing the directive has shown that:

1/ National pricing and reimbursement policies evolve at a quick
pace, so that the requirements of the directive should be based on general principles
rather than on the description of specific types of measures.

2/ The effective
monitoring of national legislation in this field of competence belonging
essentially to the Member States requires stronger information and enforcement
mechanisms.

1.5.4.     Coherence and possible
synergy with other relevant instruments

The proposal must be seen in the context of the Commission’s efforts
to reinforce the internal market and to generate favourable conditions for a
competitive pharmaceutical industry that provides safe, innovative and
accessible medicines to European citizens. It relates to a number of recent or
on-going initiatives, in particular:

1/ The Commission Communication on a renewed vision for the
pharmaceutical sector (2008), which announced that the application of Directive
89/105/EEC would be enhanced to ensure genuinely transparent and speedy pricing
and reimbursement decisions.

2/ The Commission’s
Pharmaceutical Sector Inquiry (2008-2009), which concluded that the Commission
might examine the potential need to review Directive 89/105/EEC in order to
facilitate timely market access for generic medicines.

3/ The political
initiatives to foster cooperation between Member States on pricing and
reimbursement challenges, in particular the High Level Pharmaceutical Forum
(2005-2008) and the Process on Corporate Responsibility in the Field of
Pharmaceuticals launched by the European Commission in 2010.

4/ Voluntary
cooperation between Member States on health technology assessments currently
take forward in the framework of the EUNetHTA Joint Action and to be formalised
through the implementation of Directive 2011/24/EU on the application of
patients’ rights in cross-border healthcare.

1.6.        Duration and financial
impact

ý Proposal/initiative of unlimited
duration

–
Depending on progress with the legislative
process, implementation is envisaged to begin in 2014 (adoption by Council and
Parliament) with a deadline for transposition by Member States in 2015.

1.7.              Management mode(s) envisaged[18]

ý Centralised direct management by the Commission

Comments

Member
States will be responsible for implementing the provisions of the directive.
The Commission’s role will mainly consist in:

-Facilitating and verifying the transposition of
the Directive. Budget impact: administrative expenditure (missions,
conferences, etc.) and expert support (verification of transposition).

- Facilitating the implementation of the
Directive in the context of the Committee created according to Article 10 of Directive 89/105/EEC and composed
of national representatives and chaired by the Commission services. Budget
impact: administrative expenditure for the organisation of the Committee.

- Checking the compliance with the provisions
of the Directive of draft national measures notified to the Commission. Budget
impact: this activity involves the mobilisation of additional human resources,
external translation work as well as the development of specific IT tools for
communication with Member States.

- The financial resources required will be met by
the existing resources (internal market line) which are already assigned to the
management of the actions and/or by redeployment within the DG.

2.           MANAGEMENT MEASURES

2.1.        Monitoring and reporting
rules

The proposal requires Member States to communicate to the
Commission:

1/ The criteria they use to approve the prices of medicines and to
decide whether or not to include medicinal products within the scope of the
public health insurance system. Any amendment to these criteria should be
reported as well.

2/ Specific information on the effective timing for their pricing
and reimbursement decisions (frequency: every year six
months)

/ Any draft proposal falling within the scope of the Directive
(permanent verification of compliance and early dialogue).

3/ A report on the implementation of the Directive within two years
following transposition.

The information communicated will be assessed by the Commission and,
if necessary, discussed with the Member States for appropriate follow-up.

2.2.        Management and control
system

2.2.1.     Risk(s) identified

The main risks in managing the proposed legislation relate to the
following three phases:

- Initial transposition in national laws;

- Compliance of any new national measure falling within
the scope of the Directive;

- Effective
implementation of the procedural requirements laid down in national law.

2.2.2.     Control method(s) envisaged

The control methods envisaged are described in detail in the
Transposition and Implementation Plan (TIP). They mainly consist in:

- The provision of technical expertise by the Commission
during the transposition phase;

- The adoption of interpretative guidelines by the
Commission, in cooperation with the Member States, to clarify implementation
issues, if any;

- The verification of compliance of draft national
measures by the Commission;

- The review of national implementation reports, the
drafting by the Commission of an implementation report and possible follow-up
measures.

2.3.        Measures to prevent fraud
and irregularities

This initiative does not involve any particular risk of fraud as it
only lays down procedural requirements to be followed by Member States in their
pharmaceutical pricing and reimbursement policies. The Commission will ensure
the overall management of the regulatory framework through administrative
involvement, subject to the Commission’s internal control standards.

3.           ESTIMATED FINANCIAL IMPACT OF THE
PROPOSAL/INITIATIVE

3.1.        Heading(s) of the
multiannual financial framework and expenditure budget line(s) affected

· Existing expenditure budget lines*

In order of
multiannual financial framework headings and budget lines.

Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution

Number [Description........................................] || Diff./non-diff. ([19]) || from EFTA[20] countries || from candidate countries[21] || from third countries || within the meaning of Article 18(1)(aa) of the Financial Regulation

Heading 1 || 02.03.01 – Operation and development of the internal market, particularly in the fields of notification, certification and sectoral aproximation || Diff || YES || NO || NO || NO

Heading 1 || 02.01.04.01 – Operation and development of the internal market, particularly in the fields of notification, certification and sectoral approximation --- Expenditure on administrative management || Non-Diff || YES || NO || NO || NO

- Financial headings and budget lines will
need to be adapted to the new legal basis to be adopted under the financial
perspectives 2014-2020.

3.2.        Estimated impact on
expenditure

3.2.1.     Summary of estimated impact
on expenditure

EUR million (to 3 decimal places)

Heading of multiannual financial framework: || 1 || 1.a Competitiveness for growth and employment

DG: ENTERPRISE || || || Year N = 2014 || Year N+1= 2015 || Year N+2 = 2016 || Year N+3 = 2017 || Year N+4 = 2018 || ..... Action continued ..... || TOTAL

Ÿ Operational appropriations || || || || || || || ||

02.03.01 – Operation and development of the internal market, particularly in the fields of notification, certification and sectoral approximation || Commitments || (1) || 0,645 || 0,735 || 0,585 || 0,585 || 0,585 || 0,585 || 0,585 || ...

Payments || (2) || 0,150 || 0,500 || 0,500 || 0,500 || 0,500 || 0,500 || 0,500 ||

Appropriations of an administrative nature financed  from the envelope for specific programmes[22] || || || || || || || ||

02.010401 – Operation and development of the internal market, particularly in the fields of notification, certification and sectoral approximation — Expenditure on administrative management || || (3) || 0,050 || || || || 0,200 || || ||

TOTAL appropriations for DG ENTERPRISE || Commitments || =1+1a +3 || 0,700 || 0,735 || 0,585 || 0,585 || 0,785 || 0,585 || 0,585 || ...

Payments || =2+2a +3 || 0,150 || 0,500 || 0,500 || 0,500 || 0,700 || 0,500 || 0,500 ||

Ÿ TOTAL operational appropriations || Commitments || (4) || 0,645 || 0,735 || 0,585 || 0,585 || 0,585 || 0,585 || 0,585 ||

Payments || (5) || 0,150 || 0,500 || 0,500 || 0,500 || 0,500 || 0,500 || 0,500 ||

Ÿ TOTAL appropriations of an administrative nature financed from the envelope for specific programmes || (6) || 0,050 || || || || 0,200 || || ||

TOTAL appropriations under HEADING 1 of the multiannual financial framework || Commitments || =4+ 6 || 0,700 || 0,735 || 0,585 || 0,585 || 0,785 || 0,585 || 0,585 ||

Payments || =5+ 6 || 0,200 || 0,500 || 0,500 || 0,500 || 0,700 || 0,500 || 0,500 ||

Heading of multiannual financial framework: || 5 || " Administrative expenditure "

EUR million (to 3 decimal places)

|| || || Year N = 2014 || Year N+1 = 2015 || Year N+2 = 2016 || Year N+3 = 2017 || Year N+4 = 2018 || ..... Action continued ..... || TOTAL

DG: ENTERPRISE ||

Ÿ Human resources || 0,159 || 0,508 || 0,508 || 0,508 || 0,508 || 0,508 || 0,508 || ...

Ÿ Other administrative expenditure || 0,050 || 0,050 || 0,050 || 0,050 || 0,050 || 0,050 || 0,050 ||

TOTAL DG ENTERPRISE || Appropriations || 0,209 || 0,558 || 0,558 || 0,558 || 0,558 || 0,558 || 0,558 || ...

TOTAL appropriations under HEADING 5 of the multiannual financial framework || (Total commitments = Total payments) || 0,209 || 0,558 || 0,558 || 0,558 || 0,558 || 0,558 || 0,558 ||

EUR million (to 3 decimal places)

|| || || Year N = 2014 || Year N+1 = 2015 || Year N+2 = 2016 || Year N+3 = 2017 || Year N+4 =2018 || ..... Action continued ..... || TOTAL

TOTAL appropriations under HEADINGS 1 to 5 of the multiannual financial framework || Commitments || 0,859 || 1,293 || 1,143 || 1,143 || 1,093 || 1,093 || 1,093 ||

Payments || 0,409 || 1,058 || 1,058 || 1,058 || 1,258 || 1,008 || 1,008 ||

Note: The financial resources required will
be met by the existing resources (internal market line) which are already
assigned to the management of the actions and/or by redeployment within the DG.

3.2.2.     Estimated impact on
operational appropriations

–
ý  The proposal/initiative requires the use of operational
appropriations, as explained below:

Commitment appropriations in EUR million (to 3 decimal
places)

Indicate objectives and outputs ò || || || Year N=2014 || Year N+1=2015 || Year N+2=2016 || Year N+3=2017 || ..... Action continued ..... || TOTAL

OUTPUTS

Type of output[23] || Average cost of the output || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Total number of outputs || Total cost

SPECIFIC OBJECTIVE : To continually develop existing internal market acquis and propose new legislative or non-legislative action whenever appropriate || || || || || || || || || || || || || || || ||

Translation || (A) || 0,495 || 1 || 0,495 || 1 || 0,495 || 1 || 0,495 || 1 || 0,495 || 1 || 0,495 || 1 || 0,495 || 1 || 0,495 || || ...

IT database || (B) || 0,15 || 1 || 0,15 || 0,6 || 0,09 || 0,6 || 0,09 || 0,6 || 0,09 || 0,6 || 0,09 || 0,6 || 0,09 || 0,6 || 0,09 || || ...

Transposition transposition || (C) || 0,15 || 0 || || 1 || 0,15 || 0 || || 0 || || 0 || || 0 || || 0 || || || 0,15

Sub-total for specific objective N°1 || || || || || || || || || || || || || || || ||

TOTAL COST || 2 || 0,645 || 2,6 || 0,735 || 1,6 || 0,585 || 1,6 || 0,585 || 1,6 || 0,585 || 1,6 || 0,585 || 1,6 || 0,585 || || ...

3.2.3.     Estimated impact on
appropriations of an administrative nature

3.2.3.1.  Summary

–
ý  The proposal/initiative requires the use of administrative
appropriations, as explained below.

EUR million (to 3
decimal places)

|| Year N =2014 || Year N+1 = 2015 || Year N+2 = 2016 || Year N+3 = 2017 || Year N+4 = 2018 || ..... Action continued ..... || TOTAL

HEADING 5 of the multiannual financial framework || || || || || || || ||

Human resources || 0,159 || 0,508 || 0,508 || 0,508 || 0,508 || 0,508 || 0,508 || ...

Other administrative expenditure || 0,050 || 0,050 || 0,050 || 0,050 || 0,050 || 0,050 || 0,050 ||

Subtotal HEADING 5 of the multiannual financial framework || 0,209 || 0,558 || 0,558 || 0,558 || 0,558 || 0,558 || 0,558 || ...

Outside HEADING 5[24] of the multiannual financial framework || || || || || || || ||

Human resources || || || || || || || ||

Other expenditure of an administrative nature || 0,050 || || || || 0,200 || || ||

Subtotal outside HEADING 5 of the multiannual financial framework || 0,050 || || || || || || ||

TOTAL || 0,259 || 0,558 || 0,558 || 0,558 || 0,758 || 0,558 || 0,558 || ...

3.2.3.2.  Estimated requirements of
human resources

–
ý  The proposal/initiative requires the use of human resources, as
explained below:

Estimate to be expressed in full amounts (or at most to one decimal
place)

|| Year N= 2014 || Year N+1= 2015 || Year N+2= 2016 || Year N+3= 2017 || ..... Action continued .....

Ÿ Establishment plan posts (officials and temporary agents)

02 01 01 01 (Headquarters and Commission’s Representation Offices) || 0,159 || 0,508 || 0,508 || 0,508 || 0,508 || 0,508 || ...

XX 01 01 02 (Delegations) || || || || || || ||

XX 01 05 01 (Indirect research) || || || || || || ||

10 01 05 01 (Direct research) || || || || || || ||

Ÿ External personnel (in Full Time Equivalent unit: FTE)[25]

XX 01 02 01 (CA, INT, SNE from the "global envelope") || || || || || || ||

XX 01 02 02 (CA, INT, JED, LA and SNE in the delegations) || || || || || || ||

XX 01 04 yy [26] || - at Headquarters[27] || || || || || || ||

- in delegations || || || || || || ||

XX 01 05 02 (CA, INT, SNE - Indirect research) || || || || || || ||

10 01 05 02 (CA, INT, SNE - Direct research) || || || || || || ||

Other budget lines (specify) || || || || || || ||

TOTAL || 0,159 || 0,508 || 0,508 || 0,508 || 0,508 || 0,508 || ...

XX is the
policy area or budget title concerned.

The human resources required
will be met by staff from the DG who are already assigned to management of the action
and/or have been redeployed within the DG, together if necessary with any
additional allocation which may be granted to the managing DG under the annual
allocation procedure and in the light of budgetary constraints.

Description of
tasks to be carried out:

Officials and temporary agents || Overall management of the Directive (coordination with Member States, organisation of consultative committee, legal interpretation, infringement procedures, etc.), assessment of draft national measures notified to the Commission, secretarial and administrative support.

External personnel || --

3.2.4.     Compatibility with the
current multiannual financial framework

–
ý  Proposal/initiative is compatible the current multiannual
financial framework.

–
Financial headings and budget lines will need to
be adapted to the new legal basis to be adopted under the financial
perspectives 2014-2020

–
 ̈  Proposal/initiative will entail reprogramming of the relevant
heading in the multiannual financial framework.

Note:

Financial headings and budget lines will need to be adapted to the new
legal basis to be adopted under the financial perspectives 2014-2020.

3.2.5.     Third-party contributions

–
ý The proposal/initiative does not provide for co-financing by third
parties

|| || || || || || || ||

3.3.        Estimated impact on
revenue

–
ý  Proposal/initiative has no financial impact on revenue

[1]               See
Directive 2001/83/EC of the European Parliament and the
Council of 6 November 2001 on the Community code relating to medicinal products
for human use (OJ L311,
28/11/2001, p. 67), as amended, and Regulation (EC) N°726/2004 of the European Parliament and of the Council of 31 March 2004
laying down Community procedures for the authorisation and supervision of
medicinal products for human and veterinary use and establishing a European
Medicines Agency (OJ L 136, 30.4.2004, p. 1).

[2]               See,
for instance, Case 181/82 Roussel Laboratoria [1983] ECR 3849; Case 238/82 Duphar
and Others [1984] ECR 523; Case C‑249/88 Commission v Belgium [1991] ECR
I-1275.

[3]               Council
Directive 89/105/EEC of 21 December 1988 relating to the transparency of
measures regulating the pricing of medicinal products for human use and their
inclusion in the scope of national health insurance system (OJ N°40, 11.2.1989,
p. 8).

[4]               See
Case C-424/99 Commission
of the European Communities v Republic of Austria [2001] ECR 9285; Case C-229/00 Commission of the European Communities v Republic of
Finland [2003] ECR 5727; Case C-317/05 Pohl-Boskamp
[2006] ECR I-10611; Joined Cases C‑352/07 to C‑356/07, C‑365/07
to C‑367/07 and C‑400/07 Menarini Industrie Farmaceutiche Riunite
and Others, [2009] ECR I-2495 nyr;
Case C‑62/09 Association of
the British Pharmaceutical Industry v Medicines and Healthcare Products
Regulatory Agency, [2010] ECR I-3603 nyr.

[5]               Commission
inquiry into the European pharmaceutical sector pursuant to Article 17 of
Regulation 1/2003. The results of the inquiry are published in the
Communication from the Commission: “Executive Summary of the Pharmaceutical
Sector Inquiry Report” (COM(2009)351 final) and the annexed Staff Working Document:
“Report on the Pharmaceutical Sector Inquiry”. http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/index.html.

[6]               Case
C‑245/03 Merck, Sharp & Dohme v. Belgian State [2005] ECR I‑637,
point 27.

[7]               OJ C 299, 4.10.2012, p. 81.

[8]               OJ L 40, 11.2.1989, p. 8.

[9]               OJ L 311, 28.11.2001, p. 67.

[10]             OJ L88; 4.4.2011; p.45

[11]             COM(2009)
351 final.

[12]             OJ
L 395, 30.12.1989, p. 33.

[13]             OJ L 76, 23.3.1992, p. 14.

[14]             OJ L 134, 30.4.2004, p. 114.

[15]             OJ
L 136, 30.4.2004, p. 1.

[16]             OJ L 88, 4.4.2011, p. 45.

[17]             ABM: Activity-Based Management – ABB: Activity-Based
Budgeting.

[18]             Details of management modes and references to the
Financial Regulation may be found on the BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html.

[19]             Diff.
= Differentiated appropriations / Non-diff. = Non-Differentiated Appropriations.

[20]             EFTA:
European Free Trade Association.

[21]             Candidate
countries and, where applicable, potential candidate countries from the Western
Balkans.

[22]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.

[23]             Outputs are products and services to be supplied (e.g.:
number of student exchanges financed, number of km of roads built, etc.). (A) =
translation work, (B) = IT support, (C)= Services – Verification of
transposition.

[24]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.

[25]             CA=
Contract Agent; INT= agency staff ("Intérimaire"); JED= "Jeune
Expert en Délégation" (Young Experts in Delegations); LA= Local Agent;
SNE= Seconded National Expert.

[26]             Under the ceiling for external personnel from operational appropriations (former
"BA" lines).

[27]             Essentially
for Structural Funds, European Agricultural Fund for Rural Development (EAFRD) and
European Fisheries Fund (EFF).